Quality & testing
Every lot is tested by two independent laboratories before release. Here is what we test, how we test it, and the documentation that ships with your order.
- FDA-Registered Facility
- cGTP-Compliant (21 CFR Part 1271)
- Dual-Lab COA Verified
- NTA-Verified
- USA Manufactured
Lot release panel Illustrative
- SterilityUSP <71>, 14-dayMeets spec
- EndotoxinLAL, USP <85>Meets spec
- MycoplasmaPCRNot detected
- Particle count & sizeNTA (NanoSight) · exosome lotsReported
- Post-thaw viabilityTrypan blue · hUCT-MSC97%
- IdentityFlow cytometry · hUCT-MSCISCT markers
Layout illustration. Lot results are on each Certificate of Analysis.
Two labs, every lot
The manufacturing lab tests during production. An independent third-party lab tests the same lot under separate controls. Both reports ship with your order.
Manufacturing lab
- In-process quality control during production
- Sterility and endotoxin on each lot
- Mycoplasma screening
- Cell count and viability for hUCT-MSC lots
Independent lab
- Confirmatory testing on samples from the same lot
- Separate instrumentation and controls
- Independent sterility and endotoxin verification
- Additional NTA particle characterization for exosome lots
What we test on every lot
Each product category carries a testing panel matched to its specification. These are the core tests documented on the Certificate of Analysis.
| Test | Method | Applies to | What it confirms |
|---|---|---|---|
| Sterility | USP <71> / 21 CFR 610.12, 14-day; direct inoculation and membrane filtration | All products | No bacterial or fungal growth |
| Endotoxin | Limulus amebocyte lysate (LAL), USP <85> | All products | Bacterial endotoxin within product limits |
| Mycoplasma | PCR-based detection | All products | Negative result required for release |
| Particle count & size | Nanoparticle tracking analysis (NTA, NanoSight) on the final product | Exosome products | Particle concentration and size distribution |
| Cell count | Counted per vial | hUCT-MSC | 25 million cells per vial |
| Post-thaw viability | Trypan blue exclusion after thaw | hUCT-MSC | 97% post-thaw viability |
| Identity | Flow cytometry: CD73, CD90, CD105 positive; hematopoietic markers negative (ISCT) | hUCT-MSC | Cells match MSC criteria |
| Viral panel | Lot-level viral marker panel | hUCT-MSC | Adventitious-agent screening on the lot |
Donor eligibility screening and testing under 21 CFR Part 1271, Subpart C, applies to all tissue sources and is documented separately from lot testing.
Facility & process
Products are processed in an FDA-registered tissue establishment following current good tissue practice (cGTP) under 21 CFR Part 1271.
- Quality system. Environmental monitoring, equipment qualification, personnel training and written standard operating procedures.
- Donor eligibility. Medical and social history review and required communicable-disease testing before tissue is accepted.
- 3D bioreactor culture. Cells are expanded in closed 3D systems rather than flat 2D flasks.
- Lot traceability. Each lot number traces to donor eligibility, tissue recovery, processing and test records.
Cold chain
Product integrity depends on what happens after manufacturing. Temperature control is documented from the facility to your practice.
- Exosome products
- Stored at −80 °C and shipped frozen on dry ice by overnight carrier.
- hUCT-MSC
- Cryopreserved and shipped frozen in validated cryogenic packaging. A −80 °C cryo freezer is the standard; liquid nitrogen vapor-phase storage at ≤ −140 °C is best practice.
- Temperature monitoring
- Included with every shipment.
- Validated packaging
- Insulated packaging validated for the transit duration.
- Storage & handling
- Product-specific storage and handling documentation in every order.
- On arrival
- Check the temperature record and lot number against your documentation.
Documentation that ships
These records are yours to keep for your practice's compliance files.
- Manufacturing lab COA
- In-process quality control results for the lot.
- Independent lab COA
- Confirmatory results from a separate third-party laboratory on the same lot.
- NTA report
- Particle concentration and size distribution for exosome lots.
- Viability report
- Post-thaw cell count and viability for hUCT-MSC lots.
- Donor eligibility summary
- Confirmation that donor eligibility was determined under 21 CFR Part 1271.
- Storage & handling guide
- Product-specific storage requirements.
What the claims mean
Plain definitions of the standards on this site.
- FDA-registeredThe establishment has registered and listed with the FDA, as required for facilities that recover, process, store or distribute HCT/Ps, and is subject to inspection. Registration is not FDA approval of any product.
- cGTP-compliantProcessing follows current good tissue practice requirements in 21 CFR Part 1271.
- Dual-lab COATwo separate test reports from two different laboratories for the same lot.
- NTA-verifiedExosome particle counts and sizes are measured by nanoparticle tracking analysis on the lot.
- USA manufacturedProducts are manufactured in the United States.
Quality questions
More in the full FAQ.
What does "dual-lab COA" mean?
Every lot is tested by two laboratories: the manufacturing facility's quality-control lab and a separate third-party lab. You receive both reports, so you can compare them rather than rely on one source.
What is NTA and why does it matter?
Nanoparticle tracking analysis uses laser light scattering and video tracking to count and size individual particles. It reports the particle concentration and size distribution measured in each exosome lot. We use NanoSight instrumentation. See how EVs are counted.
How is post-thaw viability verified?
A sample is thawed and stained with trypan blue, which only non-viable cells take up. The viable percentage, 97% post-thaw, is documented on the lot's Certificate of Analysis.
What donor screening is performed?
Donor eligibility is determined as required under 21 CFR Part 1271: review of medical and social history, plus required communicable-disease testing. A donor eligibility summary is available with every order.
Does FDA registration mean the products are FDA-approved?
No. Registration means the establishment is listed with the FDA and subject to inspection. It is not approval or clearance of any product. hUCT-MSC products are not FDA-approved; exosome products are topical cosmetic products.
Can I see documentation before ordering?
Yes. Request sample COAs, NTA reports and specification sheets through our contact page or your account representative.
Keep reading
-
Science LibraryHow EVs are countedReading an NTA report and what a particle count can and cannot tell you.
-
Science Library3D bioreactor culture
2D flasks vs. 3D culture, and the published yield data.
-
Science LibraryUmbilical cord tissueDonation, donor eligibility and how cord tissue compares.
-
Science LibraryBiologics glossaryPlain definitions for the terms on COAs and spec sheets.
Review the paperwork yourself
Request sample documentation, or apply for wholesale access to receive lot-specific COAs with every order. Applications are typically approved within 24 hours.
For licensed medical professionals only. Exosome products are topical cosmetic products. hUCT-MSC products are individualized and not FDA-approved; use is clinician-directed, and patients should consult their primary care provider. Stem Nova Network does not provide dosing or procedural guidance. Products are not intended to diagnose, treat, cure, or prevent any disease. Stem Nova Network is a DBA of D1D Enterprises, Inc.